Product Authorisation

Workshop on REACH and EU Biocidal Product Legislation in practice(Experiences from EU Industry)INT MARKT 48493Belgrade, Serbia

Raf Bruyndonckx1 June 2012

Procedures and Requirements

Outline

• General principles

• Procedures

• Application

• Data requirements

• Fees

• Role of industry associations

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Cefic

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• Cefic – European Chemical Industry Council

• Membership• 28 national chemical federations• > 600 companies• > 20 affiliated sector associations

• Horizontal - vertical• EU Policy Centre: REACH, International trade,

energy and climate change, HSE, logistics, R&I …• 104 Sector Groups

EBPF

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• European Biocidal Products Forum

• Sector group of Cefic

• Regulatory developments of EU biocides legislation• AS producers & BP formulators• 70 members: companies, associations, federations

• Recognised stakeholder & observer

• Implementation BPD: AS evaluation – BP authorisation

• New Regulation

EBPF – European Biocidal Products Forum

BPR - New era starting Sep 2013

• Updated EU biocides law applicable 1 Sep 2013• Regulation – directly applicable to all EU• Same principles, improved procedures – mutual

recognition, changes to products• New concepts – EU authorisation, product family• Extended scope – treated articles• European Chemicals Agency

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Abbreviations

• BPD Biocidal Product Directive 98/8/EC• BPR Biocidal Product Regulation• AS active substance• BP biocidal product• PT product type• PA product authorisation• MR mutual recognition• LoA letter of access• MS member state(s)

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Product Authorisation

General Principles

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General principles

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• Authorisation is required before placing on the market

• Authorisation is granted for max. 10 years

• Authorisation can be granted if all conditions are fulfilled:• AS is approved for relevant PT + AS source is on positive list• The product is effective• No unacceptable effects on target organism (resistance)• No unacceptable effects on HH, ENV or animal health• Chemical identity is known (impurities/residues)• Phys-chem properties acceptable for transport and use

General principles

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• A BP cannot be authorised for use by general public if:• It is classified acute tox. (dermal, oral, inhalation);• It is classified CMR 1 or 2;• It has PBT properties;• It has endocrine disrupting properties or• It has developmental neurotoxic or immunotoxic

effects

General principles

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• Dossier elements:• AS data: LoA or complete dossier• BP data: complete dossier (or LoA)• Assessment of hazard, risk (through relevant

exposure) and efficacy• Draft Summary of the biocidal Product Characteristics

(SPC)

SPC – the ID card of a BP

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• Trade name

• Authorisation holder – authorisation number

• Date of authorisation & expiry date

• Manufacturer of BP and AS

• Qualitative and quantitative composition

• Type of formulation – categories of users

• Instructions for use and safe disposal

Product Authorisation

Procedures

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Different procedures

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• (National) authorisation – provisional authorisation• Mutual recognition (in parallel or in sequence)BPR:

• Union authorisation• Coordination by ECHA, evaluation by MS, decision by

COM

• Simplified authorisation procedure

• Parallel trade authorisation

• “Same product” authorisation

Timelines

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• 2 years to submit dossier

• 2 years to grant, amend or withdraw authorisations

• 3 months for completeness check

• 12 months for first authorisation

• 2 months to apply for mutual recognition

• 4 months to recognise first authorisation

• 3 months to resolve diverging opinions

31/12/101/01/07 1/01/098/09/06

3 monthscompleteness

check(01/01 to 31/03/09)

2 monthsapplication for

mutual recognition

(01/04 to 31/05/10)

12 months1st evaluation and authorisation

(01/04/09 to 31/03/10)

4 monthsrecognition of

1st authorisation(01/06 to 30/09/10)

3 months(01/10 to 31/12/10)

††

No application/notification (30/06/09)

Failed completeness check (30/09/09)

Timelines

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Union authorisation - scope

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• Valid across all MS at once

• Similar conditions of use across the Union - guidance

• Excluded: Art 5 – PTs 14, 15, 17, 20 and 21

• Sep 2013: new AS - PTs 1, 3, 4, 5, 18 and 19

• Jan 2017: PTs 2, 6 and 13

• Jan 2020: all categories

• Assessment report by 31 Dec 2017

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• Conditions: AS in Annex I (BPR), no SoC, no nano, no

PPE, sufficiently efficient

• No requirement for a LoA to AS dossier

• Submission to the Agency

• Evaluation by a MS within 90 days

• Once authorised, notification to other MS is sufficient –

no MR

Simplified authorisation procedure

“Same product” authorisations

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• Identical products• Existing practice (NL, FI, CH, SE, DK, PT, BE, IT ...)

• Mutual recognition within a MS between companies

• Faster procedures

• Principle in BPR, follow-up regulation

Product Authorisation

Application

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R4BP

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• Register for Biocidal Products

• Electronic database – “EU catalogue of products”

• Application form – Applicant & product

• Decision and assessment report

BPR:

• Electronic submissions – no more paper

• Central communication and process management tool

• Covers both AS and BP

R4BP

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Product Authorisation

Data requirements

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General outline

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• Data on the active substance(s) – LoA to Annex I dossier

• Substances of concern

• Data on the biocidal product

• Use description – exposure assessment

• Analytical methods

• Properties/Effect/hazard assessment (PC, TOX, ENV)

• Risk assessment

• Efficacy

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Doc. IV-A or LoA*: Test and Study Reports

a.s.(s)

Doc. IV-B or LoA*: Test and Study Reports

b.p.**

Doc II-B or LoA* - Effects

Assess.** - Exposure Assess.

- Efficacy Assess.

for Biocidal Prod.2)

Doc II-A or LoA*

Effects and exposure Ass.

Active Subst.(s)2)

Doc. II-C Risk Characterisation for Biocidal Product

Doc. II Risk and Efficacy Assess.

Doc. I Overall

Summary and Assessment1)

Document III-A or LoA*

Study Summaries Active Substance(s)2)

Document III-B or LoA*: Study Summaries Biocidal Product2)

1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness

Summary Dossier

Complete Dossier

Data waiving

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• A data requirement is not relevant to the product and/or

the intended use

• A study cannot be performed because the test is not

feasible

• The outcome of a study can be accurately predicted

based on a scientific argumentation

• The outcome of the study is in no way relevant to the risk

assessment, classification and labelling or intended use

Principle approach

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• Collate info on components - AS and SoC

• Start with detailed use description

• Derive possible exposure (exclude specific routes)

• Properties/Effect/hazard assessment

• Risk assessment – Risk reduction measures

• Efficacy

Availability of data

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• Active substance dossier (LoA required)

• Co-formulants: REACH – MSDS

• Public literature

Product Authorisation

Fees

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Fees

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• Broad variation across MS

• First authorisation: 10.000 – 50.000 Euro

• Changes: 500 – 25.000 Euro

• Renewal: 500 – 50% of original fee

• Annual fee: fixed or related to sales

Role of industry associations

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Role of industry associations

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• General representation of industry

• Endeavour to be recognised stakeholder

• Consensus driven position taking

• Competition law considerations

• No specific role regarding data sharing

Useful sources of information

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• Note for guidance to applicants for PA and MR - link

• EU Evaluation Manual - link

• TNsG on data requirements – link

• TNsG on product evaluation – link

• Joint Research Centre – biocides section - link

Raf Bruyndonckx+32 2 676 7366

rbr@cefic.be